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出境医 / 临床实验 / The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery

The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery

Study Description
Brief Summary:
Electronic health records of stroke convalescent patients will be selected from the third affiliated hospital of Zhejiang Chinese Medical University from January 2012 to December 2019. Relevant clinical data will be extracted according to case data, and model-based decision tree analysis will be conducted to establish and evaluate the clinical prediction Model.

Condition or disease Intervention/treatment
Stroke Procedure: Acupuncture

Detailed Description:
Cases will be screened according to inclusion and exclusion criteria.Patients' basic information, risk factors, types of stroke, TCM diagnosis, all treatment during hospitalization, neurological impairment evaluation, imaging examination results and other contents will be recorded.Finally, statistical processing will be carried out to establish the prediction model, draw ROC curve and evaluate the model.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Acupuncture group
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
 Procedure: Acupuncture
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
Basic treatment group
Use basic treatments, such as western medicine.
 Procedure: Acupuncture
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
Outcome Measures
Primary Outcome Measures :
  1. Clinical Neurological Functional Impairment Assessment for Stroke Patients [ Time Frame: Change from neurological functional impairment score at 6 months(or the last discharge time ，which less than 6 months) ]
    To evaluate the consciousness, muscle power, dysarthria, sensory disturbancen and ataxia of stroke patients on the first day, the seventh day, the fifteenth day, the first month and the sixth month after admission (or the last time of discharge).The total score is 0-29 points. The lower the score, the less the neurological defect. The efficacy will be assessed as an improvement in the neurological functional impairment score (eg, score improvement = score at admission - score at discharge), and treatment was effective when the score was reduced by more than 18%.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be stroke convalescent patients from The Third Affiliated Hospital of Zhejiang Chinese Medical University from January 2012 to December 2019.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of stroke
  • The incidence is between 30 days and 180 days
  • Age ≥ 18 years old
  • The first onset

Exclusion Criteria:

  • Subarachnoid hemorrhage
  • transient ischemic attack
  • other intracranial lesions
  • Non-atherosclerotic thrombotic cerebral infarction
  • Surgery, trauma, congenital disability leading to limb dysfunction
Contacts and Locations

Contacts
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Contact: Huiting Yang, Bachelor +86 15757125322 momoyiyi123456@163.com

Locations
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China, Zhejiang
The Third Affiliated Hospital of Zhejiang Chinese Medical University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Huiting Yang, Bachelor    +86 15757125322    momoyiyi123456@163.com   
Sponsors and Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University
Investigators
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Study Director: Ruijie Ma, Doctor The Third Affiliated hospital of Zhejiang Chinese Medical University
Tracking Information
First Submitted Date May 7, 2019
First Posted Date May 10, 2019
Last Update Posted Date May 14, 2019
Estimated Study Start Date June 1, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2019) 		Clinical Neurological Functional Impairment Assessment for Stroke Patients [ Time Frame: Change from neurological functional impairment score at 6 months(or the last discharge time ，which less than 6 months) ]
To evaluate the consciousness, muscle power, dysarthria, sensory disturbancen and ataxia of stroke patients on the first day, the seventh day, the fifteenth day, the first month and the sixth month after admission (or the last time of discharge).The total score is 0-29 points. The lower the score, the less the neurological defect. The efficacy will be assessed as an improvement in the neurological functional impairment score (eg, score improvement = score at admission - score at discharge), and treatment was effective when the score was reduced by more than 18%.
Original Primary Outcome Measures
 (submitted: May 9, 2019) 		Neurological impairment score [ Time Frame: Change from neurological impairment score at 6 months(or the last discharge time ，which less than 6 months) ]
To evaluate the consciousness, muscle strength, movement, sensation and mutual assistance of stroke patients on the first day, the seventh day, the fifteenth day, the first month and the sixth month after admission (or the last time of discharge)
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery
Official Title The Establishment and Analysis of the Clinical Prediction Model of Acupuncture and Moxibustion for Stroke Recovery
Brief Summary Electronic health records of stroke convalescent patients will be selected from the third affiliated hospital of Zhejiang Chinese Medical University from January 2012 to December 2019. Relevant clinical data will be extracted according to case data, and model-based decision tree analysis will be conducted to establish and evaluate the clinical prediction Model.
Detailed Description Cases will be screened according to inclusion and exclusion criteria.Patients' basic information, risk factors, types of stroke, TCM diagnosis, all treatment during hospitalization, neurological impairment evaluation, imaging examination results and other contents will be recorded.Finally, statistical processing will be carried out to establish the prediction model, draw ROC curve and evaluate the model.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will be stroke convalescent patients from The Third Affiliated Hospital of Zhejiang Chinese Medical University from January 2012 to December 2019.
Condition Stroke
Intervention Procedure: Acupuncture
Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
Study Groups/Cohorts
  • Acupuncture group
    Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
    Intervention: Procedure: Acupuncture
  • Basic treatment group
    Use basic treatments, such as western medicine.
    Intervention: Procedure: Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 9, 2019) 		1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of stroke
  • The incidence is between 30 days and 180 days
  • Age ≥ 18 years old
  • The first onset

Exclusion Criteria:

  • Subarachnoid hemorrhage
  • transient ischemic attack
  • other intracranial lesions
  • Non-atherosclerotic thrombotic cerebral infarction
  • Surgery, trauma, congenital disability leading to limb dysfunction
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03946566
Other Study ID Numbers MRJ-HT-1001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Yang Huiting, The Third Affiliated hospital of Zhejiang Chinese Medical University
Study Sponsor The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborators Not Provided
Investigators
Study Director: Ruijie Ma, Doctor The Third Affiliated hospital of Zhejiang Chinese Medical University
PRS Account The Third Affiliated hospital of Zhejiang Chinese Medical University
Verification Date May 2019

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